NCT06771037 · Erin Deneke
Use of tAN® in Alcohol Withdrawal Management
What this study is about
This research study is being conducted to learn if Transcutaneous Auricular Neurostimulation (tAN®) may be effective in treating alcohol withdrawal syndrome. Transcutaneous Auricular Neurostimulation (tAN®) works by delivering small electrical stimulations to the Vagus and Trigeminal nerves. This study will be conducted over the course of five days.
View original scientific description
This research study is being conducted to learn if Transcutaneous Auricular Neurostimulation (tAN®) may be effective in treating alcohol withdrawal syndrome. Transcutaneous Auricular Neurostimulation (tAN®) works by delivering small electrical stimulations to the Vagus and Trigeminal nerves. This study will be conducted over the course of five days. Participants will be enrolled within 24 hours of entering treatment for alcohol withdrawal management. A total of 60 individuals will be enrolled and randomly assigned to either active (treatment with the device + treatment as usual) or sham (treatment as usual) group. Data will be collected on alcohol craving, use of comfort medications, sleep, and mood.
Interventions
DEVICE
Transcutaneous Auricular Neurostimulation (tAN)
Transcutaneous Auricular stimulation will be delivered using the Spark Biomedical Sparrow Link pulse generator with Sparrow Ascent earpieces. The Sparrow Link generator is based on FDA-cleared predicate Sparrow Ascent.
Primary outcome measures
Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar) score
Time frame: Baseline to end of study day 5
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in these primary outcomes between treatment and sham group. Mixed models take advantage of multiple measures from each individual, allowing for effects both between individuals and within each individual (e.g., across time). The CIWA-Ar is a 10-item scale measuring symptoms of alcohol withdrawal. The scores can range between 0-67. The total score is the sum of all scale items. Scores between 0-9 indicate absent to minimal withdrawal, Scores 10-19 indicate mild to moderate withdrawal and scores greater than 20 indicate severe withdrawal.
Amount of comfort medications utilized
Time frame: Baseline to end of study day 5
Medications such as ibuprofen, Librium, lorazepam, promethazine, loperamide, and acetaminophen are often used to treat alcohol withdrawal. A t-test will be utilized to compare medication usage between active and sham group.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ages 18 years old to 65 years old
- Entering an inpatient substance use treatment program for alcohol withdrawal management.
- Score a 27 or higher on the WHO-ASSIST V3.0
- Is proficient in English
- Score of a 4 or higher on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
- Able to provide written informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion criteria
- Age \< 18 or \> 65
- Requires medical tapering from benzodiazepines or opioids.
- Has a history of epileptic seizures or seizures due to alcohol withdrawal.
- Has a cardiac pacemaker, cochlear prosthesis, neurostimulator or other device for which tAN® would be contraindicated.
- Has abnormal ear anatomy or an ear infection is present.
- Is pregnant.
- Has any serious medical disease or condition which, in the judgment of the Principal Investigator or his/her designee, would make study participation unsafe, or would make intervention compliance difficult.
Where
- Wernersville, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2025 · Source of record for eligibility and locations